Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

UMIN ID: UMIN000045231

Registered date:14/09/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2021/09/15
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of powdered probiotic for 6 weeks
Intake of powdered placebo for 6 weeks

Outcome(s)

• Primary Outcome: Cerebral blood flow, Saliva Stress Index, Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories 2) Subjects who are under alternative treatment (acupuncture, chiropractic and etc.) or with treatment histories of within 1 month 3) Subjects with suicide thoughts 4) Subjects who regularly take foods containing Lactic acid bacteria or Bifidobacterium such as supplements 5) Subjects who regularly intake medical drugs or supplements that affect moods or fatigue 6) Subjects with medication allergy, food allergy, or serious history of these 7) Subjects who are pregnant, under lactation or expecting to be pregnant during this study 8) Subjects who participated in other study within 1 month prior to obtaining informed consent 9) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Related Information

• Primary Sponsor: Leverage Brain Inc.
• Source(s) of Monetary Support: Morinaga Milk Industry Co., Ltd.